Multi-center, Open-label, Uncontrolled Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less with Immunocompromised Medical Conditions
- Conditions
- Children with immunocompromised medical conditions
- Registration Number
- JPRN-jRCT2080221638
- Lead Sponsor
- Abbott Japan Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 20
1.Availability of parent or legal guardian who is capable and willing to give written informed consent for his/her newborn, infant or young child to participate this study.
2.Japanese newborn, infant or young child must be age of 24 months or less at the study drug administration (i.e., must not have passed his/her second birthday).
3.The subject must meet at least one of the following immunocompromised medical conditions (from [a] to [h]), and must be considered by the investigator to be a suitable candidate to receive prophylactic treatment of palivizumab:
[a] Subject has been diagnosed with combined immunodeficiency (severe combined immunodeficiency, X-linked hyper-IgM syndrome, etc.), antibody deficiency (X-linked agammaglobulinemia, common variable immunodeficiency, non-X-linked hyper-IgM syndrome, etc.) or other immunodeficiency (Wiskott-Aldrich syndrome, DiGeorge syndrome, etc.) at the time of informed consent, or
[b] Subject has been diagnosed with human immunodeficiency virus (HIV) infection.
[c] Subject has been diagnosed with Down syndrome* without a current hemodynamically significant CHD at the time of informed consent, or
[d] Subject has a history of post organ transplantation at the time of informed consent, or
[e] Subject has a history of post bone marrow transplantation at the time of informed consent, or
[f] Subject is receiving immunosuppressive chemotherapy at the start of study drug administration, or
[g] Subject is receiving systemic high dose corticosteroid therapy (prednisone equivalents 0.5 mg/kg/every other day or more, other than inhaler or topical use) at the start of study drug administration, or
[h] Subject is receiving other immunosuppressive therapy (azathioprine, methotrexate, mizoribine, mycophenolate mofetil, cyclophosphamide, cyclosporine, tacrolimus, cytokine inhibitors, etc) at the start of study drug administration.
*: The subject must have an experience with persistent respiratory symptom or regular outpatient treatment due to respiratory tract infection prior to current RSV season.
Subjects must not be enrolled in the study if they meet any of the following exclusion criteria:
1.Subject who meets the palivizumab indications already approved in Japan.
- Subject born at 28 weeks of gestation or less and who is age of 12 months or less at the start of study drug administration.
- Subject born at 29 - 35 weeks of gestation and who is age of 6 months of less at the start of study drug administration.
- Subject is age of 24 months or less with a history of bronchopulmonary dysplasia requiring medical management within the 6 months prior to the study drug administration.
- Subject is age of 24 months or less with a current hemodynamically significant CHD at the start of study drug administration.
2.Subject requires oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support at Screening and at the start of study drug administration.
3.Subject has a current active infection including RSV infection at Screening and at the start of study drug administration.
4.Subject has a serious concurrent medical condition (hepatic dysfunction, persistent seizure disorder, etc.) except those resulting in an immune deficiency condition and renal failure.
5.Subject has received palivizumab prior to the study drug administration.
6.Subject has received any other investigational agents in the past 3 months or 5 half lives prior to the investigational drug administration (whichever is longer).
7.Subject has a history of an allergic reaction or hypersensitivity to constituents of the study drug.
8.Subject has a history of serious adverse reactions or serious allergic reaction to immunoglobulin products or has a history of hypersensitivity to immunoglobulin products, blood products, or other foreign proteins.
9.Subject whose remaining days of life are expected to be less than one year at the time of informed consent.
10.It will be impossible to collect blood as scheduled from the subject.
11.Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy variable will be the rate of hospitalization caused by RSV infection from initial administration to 30 days after final administration of the study drug.
- Secondary Outcome Measures
Name Time Method The secondary efficacy variable will be the rate of requirement for oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, other mechanical respiratory support or ICU admission caused by RSV infection from initial dose to 30 days after last dose of the study drug. The duration of hospitalization, requirement for oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, other mechanical respiratory support or ICU admission will be also calculated.